A Home-Based Exercise Intervention (CAREFit-BMT) in Improving Heart Function Among Patients With High Risk Acute Myeloid Leukemia Undergoing Stem Cell Transplant

University of Washington30 enrolled

Overview

This clinical trial studies how well a home-based exercise intervention called Cardiorespiratory Fitness in Bone Marrow Transplant Program (CAREFit-BMT) works in improving heart function among patients with high risk acute myeloid leukemia (AML) undergoing stem cell transplant. Older adults and those with other medical conditions are at a higher risk for complications in the heart and blood vessels (cardiovascular). Older age at transplantation has been associated with nearly all cardiovascular complications occurring after stem cell transplant. This is likely explained by the structural and functional changes that occur in aging hearts as well as the larger burden of cardiovascular risk factors such as diabetes, high blood pressure, and obesity. CAREFit-BMT is a "prehabilitation" program, or exercise initiated prior to intensive therapy, that consists of aerobic exercises and strength training. CAREFit-BMT may be able to increase the likelihood of safe and successful transition to stem cell transplant in patients with high risk AML.

OUTLINE: Patients undergo at-home moderate-intensity aerobic exercises over 30 minutes, 5 days per week, as well as strength training over 15-30 minutes, 3 days per week for up to 12 weeks in the absence of unacceptable toxicity. Patients also undergo blood sample collection throughout the study. After completion of the study intervention, patients are followed for 12 months.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Acute Myeloid Leukemia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 years or older * Ability to understand and willingness to sign a written informed consent document * New diagnosis of acute myeloid leukemia at Fred Hutch * High-risk patients as defined by one, or more, of the following criteria: * Age 65 years or older and/or * Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) score ≥ 3 (for patients 20 years old or older) and/or * CARE-BMT score ≥ 5 * Note: HCT-CI and CARE-BMT scores will be measured at pre-screening by study staff * Able to exercise at low to moderate intensity, as evaluated by study staff * Access to a mobile smart phone * Able to read and write in English Exclusion Criteria: * Orthopedic, neurologic, or other problems that prevent safe ambulation and protocol adherence. Information on prior falls and other recent orthopedic or neurologic problems will be used to make judgment about protocol eligibility * Recurrence of AML or diagnosis of other invasive cancer * Severe anemia (hemoglobin \< 7 gm/dl) * History of severe aortic stenosis * New York Heart Association (NYHA) class IV heart failure * Severe pain with basic movement * Pregnant persons * Unable to give consent

Outcomes

Primary Outcomes

Recruitment rates (Feasibility)

Recruitment will be calculated as the proportion of eligible patients who provide informed consent, with 95% confidence intervals, and reasons for ineligibility or refusal summarized from screening logs.

Time frame: Up to 24 months

Retention rates (Feasibility)

Retention will be defined as the proportion of enrolled participants who complete the post-intervention assessment, also with 95% confidence intervals.

Time frame: Up to 24 months

Adherence to program (Feasibility)

Adherence will be evaluated from both aerobic and resistance training participation, including the percentage of prescribed sessions completed and average weekly minutes of moderate-intensity aerobic activity from wearable device data.